Ovarian CancerABT737 exvivoNCT01440504
Ex Vivo Evaluation of the Interest of the Association of Platinum With a Molecule BH3-mimetic ABT-737 in Samples of Ovarian Tumors
An observational study of Ovarian Cancer, run by Centre Francois Baclesse at 1 site in France.
Trial summary
The aim of the study is to quantify the ex vivo induction of apoptosis by ABT-737 + association platinum in samples exposed and demonstrate the value of this combination compared to the agents used alone. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- culture ex vivo with exposure to different therapeutic agents alone or in combination.
- How many people
- 36 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2010to Jan 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patient, any chemotherapy naive or ovarian surgery, ovarian cancer with at least five tumor samples does not affect the diagnostic
Who may be able to join
- Patient aged over 18 years
- Ovarian cancer patients with at least five tumor samples does not affect the diagnosis, based on other tumor masses
- Surgery of any initial chemotherapy naive
- Patient information and signed informed consent
Who cannot join
- A person deprived of liberty or under guardianship
- Insufficient tumor samples of ovarian cancer.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the study is to quantify the ex vivo induction of apoptosis by ABT-737 + association platinum in samples exposed and demonstrate the value of this combination compared to the agents used alone.
- Conditions
- Ovarian Cancer
- Being tested
- culture ex vivo with exposure to different therapeutic agents alone or in combination.
- Keywords
- Cancer, Ovarian, chemotherapy, BH3-mimetic, platin, ex-vivo
- Medical subject headings
- Ovarian Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
culture ex vivo with exposure to different therapeutic agents alone or in combination.Other
When tumor resection, tumor specimens of ovarian cancer will be made towards a culture ex vivo with exposure to different therapeutic agents alone or in combination.
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of apoptotic cells
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2011 (estimated)
- Study startApr 2010
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Francois Baclesse
- Sponsor type
- University, hospital or other
- Collaborators
- GRECAN
- Responsible party
- Sponsor
- Investigators
- JOLY Florence, Pr, Principal investigator, Centre françois Baclesse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01440504
- Sponsor's protocol ID
- ABT-737 ex vivo
- Acronym
- ABT737 exvivo
- Status last verified
- Feb 2013
- First submitted
- 15 Sep 2011
- Last updated
- 7 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ex Vivo Evaluation of the Interest of the Association of Platinum With a Molecule BH3-mimetic ABT-737 in Samples of Ovarian Tumors
- ClinicalTrials.gov ID
- NCT01440504
- Acronym / sponsor ID
- ABT737 exvivo / ABT-737 ex vivo
- Conditions
- Ovarian Cancer
- Keywords
- Cancer, Ovarian, chemotherapy, BH3-mimetic, platin, ex-vivo
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Centre Francois BaclesseUniversity, hospital or other
- Collaborators
- GRECAN
- Study start
- Apr 2010
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 26 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study is to quantify the ex vivo induction of apoptosis by ABT-737 + association platinum in samples exposed and demonstrate the value of this combination compared to the agents used alone.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient, any chemotherapy naive or ovarian surgery, ovarian cancer with at least five tumor samples does not affect the diagnostic
Key inclusion criteria (4 listed)
- Patient aged over 18 years
- Ovarian cancer patients with at least five tumor samples does not affect the diagnosis, based on other tumor masses
- Surgery of any initial chemotherapy naive
- Patient information and signed informed consent
Key exclusion criteria (2 listed)
- A person deprived of liberty or under guardianship
- Insufficient tumor samples of ovarian cancer.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| culture ex vivo with exposure to different therapeutic agents alone or in combination.When tumor resection, tumor specimens of ovarian cancer will be made towards a culture ex vivo with exposure to different therapeutic agents alone or in combination. | Other | – |
Primary outcome
rate of apoptotic cells
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
JOLY Florence, Pr principal investigator
Centre françois Baclesse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ovarian Cancer, run by Centre Francois Baclesse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rate of apoptotic cells (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2013.